COGNIS

Information about the drug that will be tested in the study

Name of drug

Dietary supplementation with CMA2 (including vitamins and amino acids: N-acetyl-L-cysteine (NAC), L-carnitine-L-tartrate (LCAT), nicotinamide (niacinamide), and L-serine))

Administration

Soluble powder to be dissolved in 200 ml preferably cold water before use. The powder can also be used on yoghurt or other food. Participants will take two daily oral doses, one dose just after breakfast and one dose just after dinner.

Is the drug already on the market for another medical condition?

No

Will all participants receive the same drug?

Participants will be selected by chance to receive one of the following options:

• CMA2
• Placebo (also called a dummy treatment which is an inactive substance identical in appearance to the drug being tested with no active therapeutic effect). Placebo will contain primarily collagen and maltodextrin.

Neither the participant nor their doctor will know if the person is receiving the investigational drug or the placebo.

Information about participating in the trial

What are the researchers trying to find out?

The purpose of the study is to evaluate the efficacy, tolerability and safety of dietary supplementation in people with Alzheimer's disease.

How long will the treatment last?

• 26 weeks with 4 visits to the clinic for check-ups and tests

What your involvement will entail?

• During the study, participants will be asked to complete tests that will assess their memory, cognition and activities of daily living (MMSE, ADAS-Cog, ADCS-ADL)
• Complete some laboratory tests and neurological examination to evaluate the emergent adverse events (unfavourable signs, symptoms or diseases temporally associated with the use of the drug tested in the study).

Further information on the procedures, tests and number of visits can be obtained from the study team.

Who can participate in this study?

Who can participate in the study?

To take part in the study, participants must:

• Be 50 years old or older
• Have a diagnosis of Alzheimer’s disease
• Have a score above 12 on the ADAS-Cog scale and above 4 on the GDS scale, suggestive of depression and indicating cognitive impairment
• Female participants of childbearing potential must have documented tubal ligation or hysterectomy; or be post-menopausal
• Have a study partner who is willing to participate in study procedures throughout the study duration

Who cannot participate in the study?

People cannot take part in the study if they have or have experienced:

• A disease that may interfere with the safety or study assessments (e.g., uncontrolled diagnosed depression, uncontrolled diabetes, chronic diarrhoea, chronic kidney disease)
• History of stroke
• History of brain trauma < 14 days
• Use of dietary supplements such as vitamins and omega-3 products
• Drug and/or alcohol abuse.

The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study.

Information for your doctor

Clinicaltrials.gov identifier

NCT07062198

Study contact information

Sibel Ertan
Phone Number: +905332722936
Email: sertan@kuh.ku.edu.tr

Link to full text

https://clinicaltrials.gov/study/NCT07062198 

The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov, CTIS websites) in September 2025.

This document has been reviewed by a member of the European Dementia Carers Working Group.